Topical Statin Eye Drop in the Management of the Dry Eye

Phase 1

Active, not recruiting

• Conditions: Dry Eye Disease
• Interventions: Drug: Statin eye drop; Drug: Placebo

• Registration Number: NCT06208384
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

In the first stage, to evaluate the safety of the topical medication produced by Sina Pharmaceuticals, this medication is experimentally tested on 10 volunteer patients. If no side effects occur, eligible patients are enrolled in the study after examination by a specialist. The second stage is a randomized, double-blind clinical trial, during which selected patients are randomly assigned to the control and intervention groups.

For patients in the intervention group, in addition to standard treatment, including eyelid hygiene and the use of artificial tears, a topical drop of Atorvastatin (50 microM) will be administered, one drop eight times a day in both eyes. In the control group, a placebo will be used in the same manner. The patients will be unaware of their assigned group.

Clinical examinations, including Schirmer's test, tear breakup time, fluorescein staining, and completion of the dry eye syndrome questionnaire and dry eye questionnaire, will be conducted before and after the intervention to assess the level of eye dryness.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-04
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-06
• Last Update Submitted: 2024-01-06
• Study First Posted: 2024-01-17
• Last Update Posted: 2024-01-17
• Primary Completion: 2025-01-04
• Study Completion: 2025-02-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age>20 years old
• Dry eye induced by Meibomian gland dysfunction
• Tear break up time less than 10 seconds

Exclusion Criteria

• Hematologic disorders
• Coagulopathies
• Use of anticoagulant medication
• Use of Peptic ulcer disease
• History of ocular surgeries in the last 3 months
• History of any ocular Malignancies
• History of ocular trauma
• History of statin use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin eye drop	Statin eye drop	Use of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Control	Placebo	Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)

Primary Outcome Measures

Name	Time	Method
Change from tear break up time at week 4 follow up	Baseline and week 4 follow up	Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 4 follow up after completion of prescription period (8 week)
Change from tear break up time at week 8 follow up	Baseline and week 8 follow up	Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 8 follow up after completion of prescription period (8 week)
Change from tear break up time at week 12 follow up	Baseline and week 12 follow up	Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 12 follow up after completion of prescription period (8 week)

Secondary Outcome Measures

Name	Time	Method
Change from Ocular Surface Disease Index at week 4 follow up	Baseline and week 4 follow up	Ocular Surface Disease Index (OSDI) Questionnaire will be completed by participants at baseline and week 4 follow up after completion of prescription period (8 week)
Change from Ocular Surface Disease Index at week 8 follow up	Baseline and week 8 follow up	Ocular Surface Disease Index (OSDI) Questionnaire will be completed by participants at baseline and week 8 follow up after completion of prescription period (8 week)
Change from Ocular Surface Disease Index at week 12 follow up	Baseline and week 12 follow up	Ocular Surface Disease Index (OSDI) Questionnaire will be completed by participants at baseline and week 12 follow up after completion of prescription period (8 week)
Change from dry eye score at week 4 follow up	Baseline and week 4 follow up	Dry Eye Questionnaire will be completed by participants at baseline and week 4 follow up after completion of prescription period (8 week)
Change from dry eye score at week 8 follow up	Baseline and week 8 follow up	Dry Eye Questionnaire will be completed by participants at baseline and week 8 follow up after completion of prescription period (8 week)
Change from dry eye score at week 12 follow up	Baseline and week 12 follow up	Dry Eye Questionnaire will be completed by participants at baseline and week 12 follow up after completion of prescription period (8 week)

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of